Maanikonda Bala Krishna* and Mukthinuthalapati Mathrusri Annapurna
GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, India
*Corresponding Author: Maanikonda Bala Krishna, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, India.
Received: February 01, 2021; Published: February 25, 2021
Citation: Maanikonda Bala Krishna and Mukthinuthalapati Mathrusri Annapurna. “A Review on Analytical Techniques for the assay of Apixaban”. Acta Scientific Pharmaceutical Sciences 5.3 (2021): 58-60.
Apixaban is an anticoagulant, or blood thinner. It makes your blood flow through your veins more easily. This means your blood will be less likely to make a dangerous blood clot. Apixaban is a selective, reversible, direct inhibitor of factor Xa indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. The present review article summarises the analytical methods so far developed for the estimation of Apixaban.
Keywords: Apixaban; Analytical Methods; Factor Xa
Apixaban is chemically 1-(4-methoxyphenyl)–7–oxo–6–[4–(2–oxopi-peridinin-1-yl) phenyl]–4, 5,6, 7–tetrahydropyrrole[3,4–c] pyridine-3-carboxamide with molecular formula C25H25N5O4 and molecular weight 459.497 g/mol and is a white to pale yellow coloured powder. It is an inhibitor of coagulation factor Xa and acts by interfering with the conversion of prothrombin to thrombin and preventing the formation of cross-linked fibrin clots. Apixaban is indicated for the prophylaxis of deep vein thrombosis. The present review article summarises the analytical methods so far developed for the estimation of Apixaban in pharmaceutical formulations as well as biological fluids. Apixaban is a highly potent, selective, and efficacious and it is an orally bioavailable inhibitor of blood coagulation factor [1]. Apixaban (BMS-562247, Eliquis TM) was developed by Bristol Myers Squibb and Pfizer to use it as an antithrombotic/anticoagulant agent [2,3]. Apixaban is approved for the prevention of stroke and systemic embolism in patients with non valvular atrial fibrillation, the prophylaxis of deep vein thrombosis which may lead to pulmonary embolism in patients who have undergone hip or knee replacement surgery [4].
Figure 1: Chemical structure of apixaban.
The present review article summarises the analytical techniques so far developed such as spectrophotometry [5-9], high performance liquid chromatography [10-13] including QbD [14] and impurity profiling [15] studies as well as liquid chromatography-mass spectrometric methods [16-18] for the determination of Apixaban (Table 1).
Reagent/Mobile phase (v/v) |
lmax (nm) |
Linearity (µg/ml) |
Comment |
Ref |
Spectrophotometric methods |
||||
Methanol |
280 |
2-10 |
- |
5 |
Methanol |
269 -289 |
5-25 |
- |
6 |
Water, Sodium Hydroxide Methanol Ethanol |
278 |
10-80 |
|
7 |
Dimethyl Sulfoxide |
282 |
5-20 |
|
8 |
Methanol |
269-289 and 266.21-304.62 |
|
Area under curve and First order derivative spectrophotometric method |
9 |
Liquid chromatographic methods |
||||
[Buffer: Methanol (90:10)]: [Buffer: Acetonitrile: Methanol (20:20:60)] (Buffer: 10 mM phosphate buffer (pH 5.0) adjusted with Triethyl amine |
235 |
0-40 |
Gradient mode |
10
|
Sodium acetate: Acetonitrile (50:50) |
- |
10 - 50 |
- |
11 |
Phosphate buffer (pH 4.5): Methanol (60:40) |
220 |
0.01 - 0.22 |
- |
12 |
Methanol: Water (50.2: 49.8) |
220 |
1 - 35 |
- |
13 |
{Buffer: Acetonitrile (90:10)}: {Water: Acetonitrile (10:90)} |
280 |
- |
QbD Impurities Stability indicating (Gradient mode) |
14 |
Phosphate buffer: Acetonitrile |
225 |
- |
Stability indicating & Process related 9 Impurities |
15 |
Liquid chromatography-Mass spectrophotometric methods |
||||
Acetonitrile: Ammonium formate buffer (pH 4.2) (70:30) |
|
0.001 - 0.301 |
LC-MS/MS
|
16 |
2.5 mM Ammonium formate (pH 3.0): 0.1% formic acid in Methanol |
|
0.01 0.5 |
UPLC-MS/MS (Gradient mode) |
17 |
0.1% aqueous formic acid: 0.1% formic acid in Acetonitrile |
|
0.0005 - 0.5 |
UHPLC-MS/MS Dried blood spots (Liquid-Liquid extraction) |
18 |
Table 1: Review of spectrophotometric methods for the determination of apixaban.
The present review article helps the readers to do research in a new field apart from the presenting existing analytical techniques for the anti-viral drug Apixaban.
Copyright: © 2021 Maanikonda Bala Krishna and Mukthinuthalapati Mathrusri Annapurna. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.